Risk analysis applied to the sterilization process in a public health hospital center: Use of the "FMECA" method

The sterilization of reusable medical devices in healthcare establishments is an activity of enormous importance in the quality and safety of medical procedures. The methods of risk analysis are the means that will put into exercise the critical points of this process.

To identify by brainstorming the different failure modes, to prioritize by considering the average criticality indices, each step of this process, and to lead to the proposal of preventive and corrective operational actions.

To upgrade the sterilization circuit, an a priori risk analysis according to the Failure Modes, Effects and Criticality Analysis (FMECA) method was carried out.

The application of the FMECA method made it possible to identify 135 of failure modes, and to classify, in descending order, the stages of the process, according to the average criticality index. The validation/storage stage was the most critical, followed by personnel, the packaging stage.

Within a hospital establishment, the implementation of a risk analysis tool for the sterilization process of reusable medical devices will ensure the safety of the patient and the staff.